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Re: hankmanhub post# 692013

Friday, 05/17/2024 12:12:34 AM

Friday, May 17, 2024 12:12:34 AM

Post# of 700447
Yes hank, the "manufacturing and clinical trial site visits" are the inspections that are referenced on page 23 of the recent 10Q. And yes, I think they are intended to be completed within the second 70 assessment period, however, as I included in my post, the MHRA is still backlogged and may not be able to complete this in the 150-day assessment timeline as intended. They are potentially all clinical trial sites and manufacturing sites directly related to the clinical trial and the MAA, as well as any current manufacturing sites (Sawston) that will be used for commercial production, and not the Eden Flaskworks system, which I believe is separate from the MAA.
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